Chapter Outlines

Chapter 2 provides an executive summary of the insights captured in our research. It offers a high-level view on the current state of the market for companion diagnostics, in the short-mid term and long term.

Chapter 3 is an introductory chapter that highlights the importance of companion diagnostics in relation to personalized medicine. The chapter describes the approaches used to develop a companion diagnostic, along with information on the various analytical techniques used in such tests. It also provides details on key market drivers and challenges within this industry. 

Chapter 4 provides a list of companion diagnostics designed for different drugs. It includes information on the corresponding drug(s) / drug class and detailed analysis on the affiliated biomarker, assay technique involved (in situ hybridization (ISH), immunohistochemistry  (IHC), next generation sequencing (NGS), polymerase chain reaction (PCR) and others), therapeutic area (oncological disorders, infectious diseases, metabolic disorders, neurological disorders, inflammatory disorders and others), the type of sample required (tumor tissue, blood, bone marrow and others) and the developer details (such as company size and location of company headquarters). 

Chapter 5 provides detailed profiles of some of the leading stakeholders in this field (shortlisted on the basis of the strength of product portfolio). Each profile presents a brief overview of the company, financial information (if available), product portfolio, recent collaborations and an informed future outlook.

Chapter 6 provides an elaborative brand positioning analysis of the leading industry players (shortlisted on the basis of the strength of product portfolio) highlighting the current perceptions regarding their proprietary brands across their companion diagnostic portfolio, taking into consideration several aspects, such as strength of product portfolio, geographical presence / reach, recent collaborations, diversity in therapeutic areas and the overall market positioning of the players.

Chapter 7 features an elaborate analysis and discussion of the various collaborations and partnerships that have been inked amongst players since 2014. It includes a brief description of various types of partnership models (which include acquisitions, licensing agreements, product development and commercialization agreements, research and development agreements, distribution and supply agreements, service alliances and other agreements) that have been adopted by stakeholders in this domain. It also includes a schematic representation that showcases the companies that have established the maximum number of alliances, highlighting key technologies and disease indications. 

Chapter 8 provides information on the needs of different stakeholders (drug developers, diagnostic developers, testing laboratories, physicians, payers and patients) involved in this domain. The chapter qualitatively assesses the various companion diagnostics-related needs of these stakeholders, highlighting their respective perspectives regarding the importance of each need. 

Chapter 9 presents a value chain analysis featuring a discussion on various steps of the development operations, namely R&D development, clinical assessment of the product, manufacturing and assembly, payer negotiation and marketing activities, of a companion diagnostic and the cost requirements across each of the aforementioned stages.

Chapter 10 provides a comprehensive clinical trial analysis of completed, ongoing and planned studies of various therapies for oncological disorders being sponsored by the top pharmaceutical players. The analysis highlights the key trends associated with these clinical studies across various parameters, such as trial start year, trial status, phase of development, key indications, type of therapy, biomarkers evaluated, enrolled patient population and regional distribution of trials

Chapter 11 features a comprehensive market forecast analysis, highlighting the likely growth of companion diagnostics till the year 2030. We have provided inputs on the likely distribution of the opportunity  based on the type of therapeutic area (oncological disorders (breast cancer, colorectal cancer, leukemia, lymphoma, melanoma, non-small cell lung cancer and ovarian cancer) and non-oncological disorders (Alzheimer’s disease and HIV)), key contributing technologies (in situ hybridization (ISH), immune histochemistry  (IHC), next generation sequencing (NGS), polymerase chain reaction (PCR) and others), different regions North America (the US), Europe (the UK, Spain, Italy, France and Germany) and Asia Pacific (Japan, China and Australia). 

Chapter 12 summarizes the entire report. It presents a list of key takeaways and offers our independent opinion on the current market scenario. Further, it captures the evolutionary trends that are likely to determine the future of this segment of the companion diagnostics industry.

Chapter 13 is a collection of interview transcript(s) of discussions held with industry stakeholders, wherever the participants didn’t request anonymity.  

Chapter 14 is an appendix, which provides tabulated data and numbers for all the figures included in the report.

Chapter 15 is an appendix, which contains a list of companies and organizations mentioned in this report.

 

Table of Contents

1.                  PREFACE

1.1.               Scope of the Report

1.2.               Research Methodology

1.3.               Chapter Outlines

 

2.                  EXECUTIVE SUMMARY

 

3.                  INTRODUCTION

3.1.               Evolution of Personalized Medicine

3.2.               An Overview of Companion Diagnostics

3.2.1.            Development of Companion Diagnostics

3.2.2.            Analytical Techniques Used in Companion Diagnostic Tests

3.2.2.1.         Immunohistochemistry

3.2.2.2.         In situ Hybridization

3.2.2.3.         Polymerase Chain Reaction

3.2.2.4.         DNA Sequencing / Next Generation Sequencing

3.2.3.            Advantages of Companion Diagnostics

3.3.               Applications of Companion Diagnostics across Different Therapeutic Areas

3.4.               Regulatory Review and Approval Process for Companion Diagnostics

3.5.               Existing Challenges and Future Roadmap

4                   CURRENT MARKET LANDSCAPE

4.1.               Chapter Overview

4.2.               Companion Diagnostics: List of Developers

4.2.1.            Analysis by Year of Establishment of Developer

4.2.2.            Analysis by Company Size and Geographical Location

 

4.3.               Companion Diagnostics: List of Available / Under Development Tests

4.3.1.            Analysis by Assay Technique Used

4.3.2.            Analysis by Target Therapeutic Area

4.3.3.            Analysis by Target Indication

4.3.4.            Analysis by Type of Biomarker

4.3.5.            Grid Analysis: Analysis by Assay Technique Used and Therapeutic Area

4.3.6.            Grid Analysis: Analysis by Target Indication and Type of Biomarker

4.3.7.            Most Active Players

4.3.8.            Analysis by Geographical Location

 

5                   COMPANY PROFILES: COMPANION DIAGNOSTICS

5.1.               Chapter Overview

5.2.               Roche

5.2.1.            Company Overview

5.2.2.            Financial Information

5.2.3.            Companion Diagnostics Portfolio

5.2.4.            Recent Collaborations

5.2.5.            Recent Developments and Future Outlook

 

5.3.               Agilent Technologies

5.3.1.            Company Overview

5.3.2.            Financial Information

5.3.3.            Companion Diagnostics Portfolio

5.3.4.            Recent Collaborations

5.3.5.            Recent Developments and Future Outlook

 

5.4.               Abbott

5.4.1.            Company Overview

5.4.2.            Financial Information

5.4.3.            Companion Diagnostics portfolio

5.4.4.            Recent Collaborations

5.4.5.            Recent Developments and Future Outlook

 

5.5.               QIAGEN

5.5.1.            Company Overview

5.5.2.            Financial Information

5.5.3.            Companion Diagnostics Portfolio

5.5.4.            Recent Collaborations

5.5.5.            Recent Developments and Future Outlook

5.6.               Myriad Genetics

5.6.1.            Company Overview

5.6.2.            Financial Information

5.6.3.            Companion Diagnostics Portfolio

5.6.4.            Recent Collaborations

5.6.5.            Recent Developments and Future Outlook

 

5.7.               Foundation Medicine

5.7.1.            Company Overview

5.7.2.            Financial Information

5.7.3.            Companion Diagnostics Portfolio

5.7.4.            Recent Collaborations

5.7.5.            Recent Developments and Future Outlook

 

6                   BRAND POSITIONING ANALYSIS OF KEY INDUSTRY PLAYERS

6.1.               Chapter Overview

6.2.               Scope and Methodology

6.3.               Brand Positioning Matrix: Roche

6.4.               Brand Positioning Matrix: Agilent Technologies

6.5.               Brand Positioning Matrix: Abbott

6.6.               Brand Positioning Matrix: QIAGEN

6.7.               Brand Positioning Matrix: Myriad Genetics

6.8.               Brand Positioning Matrix: Foundation Medicine

6.9.               Comparison of Therapeutic Areas versus Assay Techniques

6.10.             Comparison of Cancer Indications versus Assay Techniques

 

7                   PARTNERSHIPS AND COLLABORATIONS

7.1.               Chapter Overview

7.2.               Partnership Models

7.3.               Companion Diagnostics Market: List of Partnerships and Collaborations

7.4.               Analysis by Year of Partnership

7.5.               Analysis by Type of Partnership

7.6.               Analysis by Type of Partnership 2014-2016 and 2016-2019

7.7.               Analysis by Therapeutic Area

7.8.               Analysis by Biomarkers Involved

7.9.               Analysis by Drug Involved and Type of Partnership

7.10.             Analysis by Technology Platform and Type of Agreement

7.11.             Analysis by Drug Involved and Phase of Development

7.12.             Most Active Players

7.13.             Intercontinental and Intracontinental Agreements

 

8.                  STAKEHOLDER NEEDS ANALYSIS

8.1.               Chapter Overview

8.2.               Companion Diagnostics: Needs of Different Stakeholders

8.3.               Comparison of Needs of Various Stakeholders

8.3.1.            Needs of Drug Developers

8.3.2.            Needs of Companion Diagnostics Developers

8.3.3.            Needs of Regulatory Authorities

8.3.4.            Needs of Testing Laboratories

8.3.5.            Needs of Payers / Insurance Providers

8.3.6.            Needs of Physicians

8.3.7.            Needs of Patients

 

9.                  VALUE CHAIN ANALYSIS

9.1.               Chapter Overview

9.2.               Companion Diagnostics Value Chain: Cost Distribution

9.2.1.            Research and Product Development

9.2.2.            Manufacturing and Assembly

9.2.3.            Clinical Trials, FDA Approval and Other Administrative Tasks

9.2.4.            Payer Negotiation and KoL Engagement

9.2.5.            Marketing and Sales

9.3.               Companion Diagnostics Developer Operations: Key Cost Contributors

9.4.               Companion Diagnostics Co-Development Operations: Key Cost Contributors

 

10.                CLINICAL RESEARCH ON CANCER BIOMARKERS: A BIG PHARMA PERSPECTIVE

10.1.             Chapter Overview

10.2.             Methodology

10.3.             Clinical Trial Analysis

10.3.1.          List of Likely Drug Candidates for IVD Developers

10.4.             Cumulative Distribution of Biomarker-based Trials by Registration Year, 2016-2019

10.4.1.          Analysis of Biomarker-based Trials of Most Popular Biomarkers

10.4.2.          Analysis of Biomarker-based Trials of Moderately Popular Biomarkers

10.4.3.          Analysis of Biomarker-based Trials of Less Popular / Preliminary Stage Biomarkers

10.4.4.          Word Cloud of Other Emerging Biomarkers

10.4.5.          Cumulative Distribution of Trials by Registration year and Most Popular Biomarkers

10.4.6.          Cumulative Distribution of Trials by Registration year and Moderately Popular Biomarkers

10.4.7.          Cumulative Distribution of Trials by Registration year and Less Popular and Biomarkers

 

10.5.             Analysis of Biomarker-based Trials by Most Popular Indications

10.5.1.          Analysis of Biomarker-based Trials by Moderately Popular Indications

10.5.2.          Analysis of Biomarker-based Trials by Less Popular and Other Indications

10.5.3.          Word Cloud of Other Emerging Indications in Biomarker-based Clinical Trials

10.5.4.          Cumulative Distribution of Trials by Registration year and Most Popular Indication

10.5.5.          Cumulative Distribution of Trials by Registration year and Moderately Popular Indications

10.5.6.          Cumulative Distribution of Trials by Registration year and Less Popular / Preliminary Stage Indications

 

10.6.             Analysis of Biomarker-based Trials by Phase of Development

10.6.1.          Analysis of Biomarker-based Trials by Phase of Development and Most Popular Biomarkers

10.6.2.          Analysis of Biomarker-based Trials by Phase of Development and Moderately Popular Biomarkers

10.6.3.          Analysis of Biomarker-based Trials by Phase of Development and Less Popular and Other Biomarkers

10.6.4.          Analysis of Biomarker-based Trials by Phase of Development and Most Popular Indications

10.6.5.          Analysis of Biomarker-based Trials by Phase of Development and Moderately Popular Indications

10.6.6.          Analysis of Biomarker-based Trials by Phase of Development and Less Popular and Other Indications

10.7.             Analysis of Biomarker-based Trials by Sponsor

10.7.1.          Analysis of Biomarker-based Trials by Sponsor and Most Popular Biomarkers

10.7.2.          Analysis of Biomarker-based Trials by Sponsor and Moderately Popular Biomarkers

10.7.3.          Analysis of Biomarker-based Trials by Sponsor and Most Popular Indications

10.7.4.          Analysis of Biomarker-based Trials by Sponsor and Moderately Popular Indications

 

10.8.             Analysis of Biomarker-based Trials by Recruitment Status

10.9.             Analysis of Biomarker-based Trials by Therapy Design

10.10.           Analysis of Biomarker-based Trials by Geography

10.10.1.        Analysis of Biomarker-based Trials by Trial Phase and Recruitment Status

10.11.           Clinical Trials Summary: Analysis by Biomarker and Most Popular Indications

10.12.           Clinical Trials Summary: Analysis by Biomarker and Moderately Popular Indications

 

10.13.           Clinical Trials Summary: Analysis by Biomarker and Preliminary Stage Indications

 

11.                MARKET FORECAST AND OPPORTUNITY ANALYSIS

11.1              Chapter Overview

11.2.             Key Assumptions and Forecast Methodology

11.3.             Global Companion Diagnostics Market, 2019-2030   

11.3.1.          Global Companion Diagnostics Market: Distribution by Region, 2019-2030

11.3.2.          Global Companion Diagnostics Market: Distribution by Therapeutic Area, 2019-2030

11.3.3.          Global Companion Diagnostics Market: Distribution by Target Indication, 2019-2030

11.3.3.1        Global Companion Diagnostics Market for Breast Cancer, 2019-2030

11.3.3.2        Global Companion Diagnostics Market for Lung Cancer, 2019-2030

11.3.3.3        Global Companion Diagnostics Market for Colorectal Cancer, 2019-2030

11.3.3.4        Global Companion Diagnostics Market for Ovarian Cancer, 2019-2030

11.3.3.5        Global Companion Diagnostics Market for Melanoma, 2019-2030

11.3.3.6        Global Companion Diagnostics Market for Leukemia, 2019-2030

11.3.3.7        Global Companion Diagnostics Market for Lymphoma, 2019-2030

11.3.3.8        Global Companion Diagnostics Market for Alzheimer’s Disease, 2019-2030

11.3.3.9        Global Companion Diagnostics Market for HIV/AIDS, 2019-2030

11.3.4.          Global Companion Diagnostics Market: Distribution by Analytical Technique Used, 2019-2030

 

11.4.             Companion Diagnostics Market in the US, 2019-2030

11.4.1.          Companion Diagnostics Market in the US: Distribution by Therapeutic Area, 2019-2030

11.4.2.          Companion Diagnostics Market in the US: Distribution by Target Indication, 2019-2030

11.4.3.          Companion Diagnostics Market in the US: Distribution by Analytical Technique Used, 2019-2030

 

11.5.             Companion Diagnostics Market in EU5, 2019-2030

11.5.1.          Companion Diagnostics Market in EU5: Distribution by Therapeutic Area, 2019-2030

11.5.2.          Companion Diagnostics Market in EU5: Distribution by Target Indication, 2019-2030

11.5.3.          Companion Diagnostics Market in EU5: Distribution by Analytical Technique Used, 2019-2030

11.6.             Companion Diagnostics Market in Japan, 2019-2030

11.6.1.          Companion Diagnostics Market in Japan: Distribution by Therapeutic Area, 2019-2030

11.6.2.          Companion Diagnostics Market in Japan: Distribution by Target Indication, 2019-2030

11.6.3.          Companion Diagnostics Market in Japan: Distribution by Analytical Technique Used, 2019-2030 

11.7.             Companion Diagnostics Market in China, 2019-2030

11.7.1.          Companion Diagnostics Market in China: Distribution by Therapeutic Area, 2019-2030

11.7.2.          Companion Diagnostics Market in China: Distribution by Target Indication, 2019-2030

11.7.3.          Companion Diagnostics Market in China: Distribution by Analytical Technique Used, 2019-2030

 

11.8.             Companion Diagnostics Market in Australia, 2019-2030

11.8.1.          Companion Diagnostics Market in Australia: Distribution by Therapeutic Area, 2019-2030

11.8.2.          Companion Diagnostics Market in Australia: Distribution by Type of Indication, 2019-2030

11.8.3.          Companion Diagnostics Market in Australia: Distribution by Type of Analytical Technique Used, 2019-2030

 

12.                CONCLUDING REMARKS

 

13.                EXECUTIVE INSIGHTS

 

14.                APPENDIX 1: TABULATED DATA

 

15.       APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

List of Figures

Figure 3.1        Evolution of Personalized Medicine, 2012-2017

Figure 3.2        Preclinical Development of Biomarker-based, Targeted Therapies

Figure 3.3        Role of Companion Diagnostics in Clinical Trials

Figure 3.4        Companion Diagnostics: Key Advantages

Figure 3.5        Companion Diagnostics: Primary Development-related Challenges

Figure 3.6        Companion Diagnostics: Market Drivers and Constraints

Figure 4.1        Companion Diagnostics: Distribution by Year of Establishment

Figure 4.2        Companion Diagnostics: Distribution by Company Size and Geographical Location

Figure 4.3        Companion Diagnostics: Distribution by Assay Technique Used

Figure 4.4        Companion Diagnostics: Distribution by Target Therapeutic Area

Figure 4.5        Companion Diagnostics: Distribution by Target Indication

Figure 4.6        Companion Diagnostics: Distribution by Type of Biomarker

Figure 4.7        Grid Analysis: Distribution by Target Indication and Type of Biomarker

Figure 4.8        Grid Analysis: Analysis by Type of Assay Technique Used and Therapeutic Area

Figure 4.9        Companion Diagnostics: Most Active Players

Figure 4.10      Companion Diagnostics: Distribution by Geographical Location

Figure 5.1        Roche: Annual Revenues, 2014-2018 (CHF Billion)

Figure 5.2        Agilent Technologies: Annual Revenues, 2014-2018 (USD Billion)

Figure 5.3        Agilent Technologies Annual Revenues: Distribution by Business Segment, 2018

(USD Billion)

Figure 5.4        Abbott: Annual Revenues, 2013-2018 (USD Billion)

Figure 5.5        Abbott Annual Revenues: Distribution by Business Segment, 2018 (USD Billion)

Figure 5.6        QIAGEN: Annual Revenues, 2014–2018 (USD Billion)

Figure 5.7        QIAGEN Net Sales: Distribution by Region, 2017 (USD Million)

Figure 5.8        Myriad Genetics: Annual Revenues, 2014-2018 (USD Million)

Figure 5.9        Myriad Genetics, Annual Revenues: Distribution by Testing Services, 2018 (USD Million)

Figure 5.10      Foundation Medicine: Annual Revenues, 2014-Q1 2018 (USD Million)

Figure 6.1        Brand Positioning Analysis of Key Industry Players: Unfair Advantages

Figure 6.2        Brand Positioning Analysis of Key Industry Players: Reasons to Believe

Figure 6.3        Brand Positioning Matrix: Roche

Figure 6.4        Brand Positioning Matrix: Agilent Technologies

Figure 6.5        Brand Positioning Matrix: Abbott

Figure 6.6        Brand Positioning Matrix: QIAGEN

Figure 6.7        Brand Positioning Matrix: QIAGEN

Figure 6.8        Brand Positioning Matrix: Myriad Genetics

Figure 6.9        Brand Positioning: Therapeutic Areas and Assay Techniques

Figure 6.10      Brand Positioning: Cancer Indications and Assay Techniques

Figure 7.1        Partnerships and Collaborations: Analysis by Year of Partnership

Figure 7.2        Partnerships and Collaborations: Analysis by Type of Partnership

Figure 7.3        Partnerships and Collaborations: Analysis by Type of Partnership 2014-2016 and 2016-2019

Figure 7.4        Partnerships and Collaborations: Analysis by Therapeutic Area

Figure 7.5        Partnerships and Collaborations: Analysis by Biomarkers Involved

Figure 7.6        Partnerships and Collaborations: Analysis by Drug Involved and Type of Partnership

Figure 7.7        Partnerships and Collaborations: Analysis by Technology Platform and Type of Agreement

Figure 7.8        Partnerships and Collaborations: Analysis by Drug Involved and Phase of Development

Figure 7.9        Most Active Players: Analysis by Number of Partnerships

Figure 7.10      Partnerships and Collaborations: Intercontinental and Intracontinental Distribution

Figure 8.1        Stakeholder Needs Analysis: Comparison of Needs of Different Stakeholders

Figure 8.2        Stakeholder Needs Analysis: Comparison of Needs of Various Stakeholders

Figure 8.3        Stakeholder Needs Analysis: Comparison of Needs of Companion Diagnostics

Developers

Figure 8.4        Stakeholder Needs Analysis: Needs of Regulatory Authorities

Figure 8.5        Stakeholder Needs Analysis: Needs of Testing Laboratories

Figure 8.6        Stakeholder Needs Analysis: Needs of Payers / Insurance Providers

Figure 8.7        Stakeholder Needs Analysis: Needs of Physicians

Figure 8.8        Stakeholder Needs Analysis: Needs of Patients

Figure 9.1        Companion Diagnostics Value Chain: Cost Distribution

Figure 9.2        Companion Diagnostics Value Chain: Research and Product Development

Figure 9.3        Companion Diagnostics Value Chain: Manufacturing and Assembly

Figure 9.4        Companion Diagnostics Value Chain: Clinical Trials, FDA Approval and Other Administrative Tasks

Figure 9.5        Companion Diagnostics Value Chain: Payer Negotiation and KoL Engagement

Figure 9.6        Companion Diagnostics Value Chain: Marketing and Sales

Figure 9.7        Companion Diagnostics Developer Operations: Key Cost Contributors

Figure 9.8        Companion Diagnostics Co-Development Operations: Key Cost Contributors

Figure 10.1     Clinical Trial Analysis: Distribution by Registration Year

Figure 10.2     Clinical Trial Analysis: Distribution by Most Popular Biomarkers

Figure 10.3     Clinical Trial Analysis: Distribution by Moderately Popular Biomarkers

Figure 10.4     Clinical Trial Analysis: Distribution by Less Popular / Preliminary Stage Biomarkers

Figure 10.5     Word Cloud: Other Emerging Biomarkers

Figure 10.6     Clinical Trial Analysis: Distribution by Registration Year and Most Popular Biomarkers

Figure 10.7     Clinical Trial Analysis: Distribution by Registration Year and Moderately Popular Biomarkers

Figure 10.8     Clinical Trial Analysis: Distribution by Registration Year of Less Popular and Other Biomarkers

Figure 10.9     Clinical Trial Analysis: Distribution by Most Popular Indications

Figure 10.10   Clinical Trial Analysis: Distribution by Moderately Popular Indications

Figure 10.11   Clinical Trial Analysis: Distribution by Less Popular and Other Indications

Figure 10.12   Word Cloud: Less Popular and Other Indications

Figure 10.13   Clinical Trial Analysis: Distribution by Registration Year and Most Popular Indications

Figure 10.15   Clinical Trial Analysis: Distribution by Trial Registration Year and Moderately Popular Indications

Figure 10.16   Clinical Trial Analysis: Distribution by Trial Registration Year and Less Popular and Other Indications

Figure 10.17   Clinical Trial Analysis: Distribution by Trial Phase

Figure 10.18   Clinical Trial Analysis: Distribution by Trial Phase and Most Popular Biomarkers

Figure 10.19   Clinical Trial Analysis: Distribution by Trial Phase and Moderately Popular Biomarkers

Figure 10.20   Clinical Trial Analysis: Distribution by Trial Phase and Less Popular and Other Biomarkers

Figure 10.21   Clinical Trial Analysis: Distribution by Trial Phase and Most Popular Indications

Figure 10.22   Clinical Trial Analysis: Distribution by Trial Phase and Moderately Popular Indications

Figure 10.23   Clinical Trial Analysis: Distribution by Trial Phase and Less Popular / Emerging Indications

Figure 10.24   Clinical Trial Analysis: Distribution of Trials by Sponsor

Figure 10.25   Clinical Trial Analysis: Distribution by Sponsor and Most Popular Biomarkers

Figure 10.26   Clinical Trial Analysis: Distribution by Sponsor and Moderately Popular Biomarkers

Figure 10.27   Clinical Trial Analysis: Distribution by Sponsor and Most Popular Indications

Figure 10.28   Clinical Trial Analysis: Distribution by Sponsor and Moderately Popular Indications

Figure 10.29   Clinical Trial Analysis: Distribution by Trial Recruitment Status

Figure 10.30   Clinical Trial Analysis: Distribution of Trials by Therapy Design

Figure 10.31   Clinical Trial Analysis: Distribution of Trials by Recruitment Status

Figure 10.32   Clinical Trial Analysis: Distribution of Trials by Number of Clinical Trials by Enrolled Patient Population

Figure 10.33   Biomarker-focused Clinical Trials of Lung Cancer: Number of Trials and Affiliated Biomarkers

Figure 10.34   Biomarker-focused Clinical Trials of Breast Cancer: Number of Trials and Affiliated Biomarkers

Figure 10.35   Biomarker-focused Clinical Trials of Lymphoma: Number of Trials and Affiliated Biomarkers

Figure 10.36 Biomarker-focused Clinical Trials of Ovarian Cancer: Number of Trials and Affiliated Biomarkers

Figure 10.37   Biomarker-focused Clinical Trials of Prostate Cancer: Number of Trials and Affiliated Biomarkers

Figure 10.38   Biomarker-focused Clinical Trials of Melanoma: Number of Trials and Affiliated Biomarkers

Figure 10.39   Biomarker-focused Clinical Trials of Colon / Colorectal Cancer: Number of Trials and Affiliated Biomarkers

Figure 10.40   Biomarker-focused Clinical Trials of Head and Neck Cancer: Number of Trials and Affiliated Biomarkers

Figure 11.1      Global Companion Diagnostics Market: 2019-2030 (USD Billion)

Figure 11.2      Global Companion Diagnostics Market: Distribution by Region, 2019-2030 (USD Billion)

Figure 11.3      Global Companion Diagnostics Market: Distribution by Therapeutic Area,

2019-2030 (USD Billion)

Figure 11.4      Global Companion Diagnostics Market: Distribution by Target Indication, 2019-2030 (USD Billion)

Figure 11.5      Global Companion Diagnostics Market for Breast Cancer, 2019-2030 (USD Billion)

Figure 11.6     Global Companion Diagnostics Market for Lung Cancer, 2019-2030 (USD Billion)

Figure 11.7      Global Companion Diagnostics Market for Colorectal Cancer, 2019-2030 (USD Billion)

Figure 11.8      Global Companion Diagnostics Market for Ovarian Cancer, 2019-2030 (USD Billion)

Figure 11.9      Global Companion Diagnostics Market for Melanoma, 2019-2030 (USD Billion)

Figure 11.10    Global Companion Diagnostics Market for Leukemia, 2019-2030 (USD Billion)

Figure 11.11    Global Companion Diagnostics Market for Lymphoma, 2019-2030 (USD Billion)

Figure 11.12    Global Companion Diagnostics Market for Alzheimer’s Disease, 2019-2030 (USD Billion)

Figure 11.13    Global Companion Diagnostics Market for HIV/AIDS, 2019-2030 (USD Billion)

Figure 11.14    Global Companion Diagnostics Market, Distribution by Type of Analytical Technique Used, 2019-2030 (USD Billion)

Figure 11.15    Companion Diagnostics Market in the US, 2019-2030 (USD Billion)

Figure 11.16    Companion Diagnostics Market in the US: Distribution by Therapeutic Area, 2019-2030 (USD Billion)

Figure 11.17    Companion Diagnostics Market in the US: Distribution by Target Indication, 2019-2030 (USD Billion)

Figure 11.18    Companion Diagnostics Market in the US: Distribution by Analytical Technique, 2019-2030 (USD Billion)

Figure 11.19    Companion Diagnostics Market in EU5, 2019-2030 (USD Billion)

Figure 11.20    Companion Diagnostics Market in EU5: Distribution by Therapeutic Area, 2019-2030 (USD Billion)

Figure 11.21    Companion Diagnostics Market in EU5: Distribution by Target Indication, 2019-2030 (USD Billion)

Figure 11.22   Companion Diagnostics Market in EU5: Distribution by Type of Analytical Technique, 2019-2030 (USD Billion)

Figure 11.23    Companion Diagnostics Market in Japan, 2019-2030 (USD Billion)

Figure 11.24    Companion Diagnostics Market in Japan: Distribution by Therapeutic Area, 2019-2030 (USD Billion)

Figure 11.25    Companion Diagnostics Market in Japan: Distribution by Target Indication,

2019-2030 (USD Billion)

Figure 11.26    Companion Diagnostics Market in Japan: Distribution by Analytical Technique,                  2019-2030 (USD Billion)

Figure 11.27    Companion Diagnostics Market in China, 2019-2030 (USD Billion)

Figure 11.28    Companion Diagnostics Market in China: Distribution by Therapeutic Area, 2019-2030 (USD Billion)

Figure 11.29    Companion Diagnostics Market in China: Distribution by Target Indication, 2019-2030 (USD Billion)

Figure 11.30    Companion Diagnostics Market in China: Distribution by Analytical Technique,         2019-2030 (USD Billion)

Figure 11.31   Companion Diagnostics Market in Australia, 2019-2030 (USD Billion)

Figure 11.32    Companion Diagnostics Market in Australia: Distribution by Therapeutic Area, 2019-2030 (USD Billion)

Figure 11.33    Companion Diagnostics Market in Australia: Distribution by Target Indication,

2019-2030 (USD Billion)

Figure 11.34    Companion Diagnostics Market in Australia: Distribution by Analytical Technique, 2019-2030 (USD Billion)

List of Tables

Table 4.1         Companion Diagnostics: List of Developers

Table 4.2         Companion Diagnostics: Tests Available and Under Development

Table 5.1         Companion Diagnostics: List Companies Profiled

Table 5.2         Roche: Other Companion Diagnostics

Table 5.3         Roche: Recent Developments and Future Outlook

Table 5.4         Agilent: Other Companion Diagnostics

Table 5.5         Agilent Technologies: Recent Developments and Future Outlook

Table 5.6         Abbott: Other Companion Diagnostics

Table 5.7         Abbott: Recent Developments and Future Outlook

Table 5.8         QIAGEN: Other Companion Diagnostics

Table 5.9         QIAGEN: Recent Developments and Future Outlook

Table 5.10       Myriad Genetics: Other Companion Diagnostics

Table 5.11       Myriad Genetics: Recent Developments and Future Outlook

Table 5.12       FoundationOne CDx: Target Indications

Table 5.13       Foundation Medicine: Other Companion Diagnostics

Table 5.14       Foundation Medicine: Recent Developments and Future Outlook

Table 7.1         Companion Diagnostics: Partnerships and Collaborations, 2014-2019

Table 10.1       List of Likely Drug Candidates / Potential Collaborators for Diagnostic Developers

Table 10.2       List of Biomarkers across Moderately Popular Indications

Table 10.3       List of Biomarkers Across Emerging Indications

Table 14.1      Companion Diagnostics Developers: Distribution by Year of Establishment of Developer

Table 14.2      Companion Diagnostics Developers: Distribution by Company Size and Geographical Location

Table 14.3      Companion Diagnostics: Distribution by Assay Technique Used

Table 14.4      Companion Diagnostics: Distribution by Commercial Availability and Therapeutic Area

Table 14.5      Companion Diagnostics: Distribution by Type of Indication

Table 14.6      Companion Diagnostics: Distribution by Type of Sample Used

Table 14.7      Companion Diagnostics: Distribution by Type of Biomarker

Table 14.8      Companion Diagnostics: Most Active Players

Table 14.9      Geographical Landscape

Table 14.10    Roche: Annual Revenue, FY2014-FY2018 (CHF Billion)

Table 14.11    Agilent Technologies: Total Revenue, FY 2014-FY 2018 (USD Billion)

Table 14.12    Agilent Technologies, Total Revenue: Distribution by Business Segment, FY 2018 (USD Billion)

Table 14.13    Abbott: Total Revenue, FY 2014-FY 2018 (USD Billion)

Table 14.14    Abbott, Net Sales: Distribution by Business Segment, FY 2018 (USD Billion)

Table 14.15    QIAGEN: Total Revenue, FY 2014-Q3FY 2018 (USD Billion)

Table 14.16    QIAGEN, Net Sales: Distribution by Region, FY 2018 (USD Million)

Table 14.17    Myriad Genetics: Annual Revenue, FY 2014-FY 2018 (USD Million)

Table 14.18    Myriad Genetics, Annual Revenue: Distribution by Testing Services, FY 2018 (USD Million)

Table 14.19    Foundation Medicine: Annual Revenue, 2014-FY-Q1 2018 (USD Million)

Table 14.20    Partnerships and Collaborations: Cumulative Trend by Year, 2014-2019

Table 14.21    Partnerships and Collaborations: Distribution by Type of Partnership

Table 14.22    Partnerships and Collaborations: Distribution by Type of Partnership in 2014-2016 and Post 2016

Table 14.23    Partnerships and Collaborations: Distribution by Therapeutic Area

Table 14.24    Partnerships and Collaborations: Analysis by Phase of Development of Affiliated Drug Candidates

Table 14.25    Partnerships and Collaborations: Most Active Players

Table 14.26    Cost Distribution Across Value Chain

Table 14.27    Clinical Trial Analysis: Distribution by Registration Year

Table 14.28    Clinical Trial Analysis: Distribution by Registration Year and Most Popular Biomarkers

Table 14.29    Clinical Trial Analysis: Distribution by Registration Year and Moderately Popular Biomarkers

Table 14.30    Clinical Trial Analysis: Distribution by Registration Year and Less Popular and Other Biomarkers

Table 14.31    Clinical Trial Analysis: Distribution by Registration Year and Most Popular Indications

Table 14.32    Clinical Trial Analysis: Distribution by Trial Registration Year and Moderately Popular Indications

Table 14.33    Clinical Trial Analysis: Distribution by Trial Registration Year and Less Popular and Other Indications

Table 14.34    Clinical Trial Analysis: Distribution by Trial Phase

Table 14.35    Clinical Trial Analysis: Distribution by Trial Phase and Most Popular Biomarkers

Table 14.36    Clinical Trial Analysis: Distribution by Trial Phase and Moderately Popular Biomarkers

Table 14.37    Clinical Trial Analysis: Distribution by Trial Phase and Less Popular and Other Biomarkers

Table 14.38    Clinical Trial Analysis: Distribution by Trial Phase and Most Popular Indications

Table 14.39    Clinical Trial Analysis: Distribution by Trial Phase and Moderately Popular Indications

Table 14.40    Clinical Trial Analysis: Distribution by Trial Phase and Less Popular and Other Indications

Table 14.41    Clinical Trial Analysis: Distribution of Trials by Sponsor

Table 14.42    Clinical Trial Analysis: Distribution by Trial Recruitment Status

Table 14.43    Clinical Trial Analysis: Distribution of Trials by Therapy Design

Table 14.44    Global Companion Diagnostics Market, Conservative, Base and Optimistic Scenario, 2019-2030 (USD Million)

Table 14.45    Global Companion Diagnostics Market: Distribution by Region, 2019-2030

Table 14.46    Global Companion Diagnostics Market: Distribution by Therapeutic Area, 2019-2030

Table 14.47    Global Companion Diagnostics Market: Distribution by Target Indications, 2019-2030

Table 14.48    Global Companion Diagnostics Market for Lung Cancer, Conservative, Base and Optimistic Scenario, 2019-2030 (USD Million)

Table 14.49    Global Companion Diagnostics Market for Breast Cancer, Conservative, Base and Optimistic Scenario, 2019-2030 (USD Million)

Table 14.50    Global Companion Diagnostics Market for Colorectal Cancer, Conservative, Base and Optimistic Scenario, 2019-2030 (USD Million)

Table 14.51    Global Companion Diagnostics Market for Melanoma, Conservative, Base and Optimistic Scenario, 2019-2030 (USD Million)

Table 14.52    Global Companion Diagnostics Market for Ovarian Cancer, Conservative, Base and Optimistic Scenario, 2019-2030 (USD Million)

Table 14.53    Global Companion Diagnostics Market for Leukemia, Conservative, Base and Optimistic Scenario, 2019-2030 (USD Million)

Table 14.54    Global Companion Diagnostics Market for Lymphoma, Conservative, Base and Optimistic Scenario, 2019-2030 (USD Million)

Table 14.55    Global Companion Diagnostics Market for Alzheimer’s Disease, Conservative, Base and Optimistic Scenario, 2019-2030 (USD Million)

Table 14.56    Global Companion Diagnostics Market for HIV / AIDS, Conservative, Base and Optimistic Scenario, 2019-2030 (USD Million)

Table 14.57    Global Companion Diagnostics Market: Distribution by Analytical Techniques, 2019-2030

Table 14.58    Global Companion Diagnostics Market in the US, Conservative, Base and Optimistic Scenario, 2019-2030 (USD Million)

Table 14.59    Companion Diagnostics Market in the US: Distribution by Therapeutic Area, 2019-2030 (USD Million)

Table 14.60    Companion Diagnostics Market in the US: Distribution by Target Indication, 2019-2030 (USD Million)

Table 14.61    Companion Diagnostics Market in the US: Distribution by Analytical Techniques, 2019-2030 (USD Million)

Table 14.62    Global Companion Diagnostics Market in the EU5, Conservative, Base and Optimistic Scenario, 2019-2030 (USD Million)

Table 14.63    Companion Diagnostics Market in the EU5: Distribution by Therapeutic Area, 2019-2030 (USD Million)

Table 14.64    Companion Diagnostics Market in the EU5: Distribution by Target Indication, 2019-2030 (USD Million)

Table 14.65    Companion Diagnostics Market in the EU5: Distribution by Analytical Techniques, 2019-2030 (USD Million)

Table 14.66    Global Companion Diagnostics Market in the Other European Nations, Conservative, Base and Optimistic Scenario, 2019-2030 (USD Million)

Table 14.67    Companion Diagnostics Market in the Other European Nations: Distribution by Therapeutic Area, 2019-2030 (USD Million)

Table 14.68    Companion Diagnostics Market in the Other European Nations: Distribution by Target Indication, 2019-2030 (USD Million)

Table 14.69    Companion Diagnostics Market in the Other European Nations: Distribution by Analytical Techniques, 2019-2030 (USD Million)

Table 14.70    Global Companion Diagnostics Market in Japan, Conservative, Base and Optimistic Scenario, 2019-2030 (USD Million)

Table 14.71    Companion Diagnostics Market in Japan: Distribution by Therapeutic Area, 2019-2030 (USD Million)

Table 14.72    Companion Diagnostics Market in Japan: Distribution by Target Indication, 2019-2030 (USD Million)

Table 14.73    Companion Diagnostics Market in Japan: Distribution by Analytical Techniques, 2019-2030 (USD Million)

Table 14.74    Global Companion Diagnostics Market in China, Conservative, Base and Optimistic Scenario, 2019-2030 (USD Million)

Table 14.75    Companion Diagnostics Market in China: Distribution by Therapeutic Area, 2019-2030 (USD Million)

Table 14.76    Companion Diagnostics Market in China: Distribution by Target Indication, 2019-2030 (USD Million)

Table 14.77    Companion Diagnostics Market in China: Distribution by Analytical Techniques, 2019-2030 (USD Million)

Table 14.78    Global Companion Diagnostics Market in Australia, Conservative, Base and Optimistic Scenario, 2019-2030 (USD Million)

Table 14.79    Companion Diagnostics Market in Australia: Distribution by Therapeutic Area, 2019-2030 (USD Million)

Table 14.80    Companion Diagnostics Market in Australia: Distribution by Target Indication, 2019-2030 (USD Million)

Table 14.81    Companion Diagnostics Market in Australia: Distribution by Analytical Techniques, 2019-2030 (USD Million)

List of Companies

1. AB-Biotics
2. Abbott Laboratories
3. AbbVie
4. Abcam
5. Abnova
6. Acobiom
7. AdnaGen
8. Advanced Cell Diagnostics
9. Agena Bioscience
10. Agendia
11. Agilent Technologies
12. Agios Pharmaceuticals
13. Alere 
14. Allergan
15. Allele Frequency Community
16. Almac
17. Alpha Laboratories
18. AltheaDx
19. Altona Diagnostics 
20. Amgen
21. Amoy Diagnostics
22. ANGLE 
23. Angsana Molecular & Diagnostics Laboratory
24. Applied Spectral Imaging
25. ArcherDX
26. ARIAD Pharmaceuticals
27. Arno Therapeutics
28. Array BioPharma
29. Arrayit
30. ARUP Laboratories
31. Assurex Health
32. Astellas Pharma
33. AstraZeneca
34. Asuragen
35. Avant Diagnostics
36. AVEO Oncology
37. Bayer
38. BeiGene
39. Biocartis
40. Biodesix
41. BioGenex
42. BioMarin
43. bioMérieux
44. Biotype Diagnostic 
45. Bliss Biopharmaceutical
46. Blueprint Medicines
47. Bristol-Myers Squibb
48. Boehringer Ingelheim
49. CANbridge Life Sciences
50. Cancer Genetics
51. CBLPath
52. Celgene
53. Cell Signaling Technology 
54. Clovis Oncology
55. Corgenix
56. Counsyl
57. Daiichi Sankyo
58. DalCor Pharmaceuticals 
59. Definiens
60. Dian Diagnostics Group
61. Eli Lilly
62. Epic Sciences
63. Epizyme
64. European Organization for the Research and Treatment of Cancer
65. Exact Sciences
66. Exiqon
67. Exosome Diagnostics
68. Ferring Pharmaceuticals
69. Five Prime Therapeutics
70. Flagship Biosciences
71. Flatiron Health 
72. Foundation Medicine
73. Galmed Pharmaceuticals
74. GenDx
75. GeneCast Biotechnology
76. Genomas
77. Genomic Health
78. Genoptix
79. Genosity
80. Gilead Sciences
81. GlaxoSmithKline
82. Guardant Health
83.  Guangzhou KingMed Diagnostics Group
84. HalioDx
85. Halozyme Therapeutics
86. Hitachi 
87. Horizon Discovery
88. HTG Molecular Diagnostics
89. IDbyDNA 
90. Idera Pharmaceuticals
91. Ignyta
92. Illumina
93. Immuron
94. Incyte
95. InDex Pharmaceuticals
96. IndivuTest
97. Inotrem
98. Invivoscribe 
99. IQVIA
100. Janssen Biotech
101. Jiangsu Hengrui Medicine
102. Johnson & Johnson
103. Lab21
104. Labceutics
105. LabCorp
106. Leica Biosystems
107. Life Technologies
108. LipoScience
109. Locus Biosciences
110. Loxo Oncology
111. Luminex
112. Luxcel Biosciences
113. MDxHealth
114. Medical & Biological Laboratories
115. Medivation 
116. Merck
117. Merrimack Pharmaceuticals
118. MetaStat
119. MicroMatrices
120. Mirati Therapeutics 
121. MolecularMD
122. Monogram Biosciences
123. Mount Sinai Health System 
124. Myriad Genetics
125. NanoString Technologies
126. National Institute of Pathology
127. NeoGenomics
128. NeuMoDx Molecular
129. Nichirei Biosciences
130. N-of-One
131. Novartis
132. Novo Nordisk
133. NuSirt Biopharma
134. OmicSoft
135. OmniSeq
136. OncoMed Pharmaceuticals
137. Ono Pharmaceutical 
138. OWL Metabolomics
139. PerkinElmer
140. Pfizer
141. Philips
142. Phoenix Molecular Designs 
143. Pierre Fabre
144. ProSciento
145. Protagen
146. Puma Biotechnology
147. Q2 Solutions
148. QED Therapeutics
149. QIAGEN
150. Quest Diagnostics
151. R-Biopharm
152. Resonance Health
153. Riken Genesis
154. Roche
155. Sanofi
156. Sarah Cannon Research Institute 
157. School for Oncology and Developmental Biology
158. Seahorse Bioscience
159. Shuwen Biotech
160. Siemens Healthineers 
161. Singulex
162. Sividon Diagnostics
163. Spectrum Pharmaceuticals
164. SRL Diagnostics
165. STATdx 
166. Streck
167. Sysmex
168. Takeda Pharmaceuticals
169. Teva Pharmaceutical
170. TESARO
171. The Jackson Laboratory
172. Therawis Diagnostics 
173. Thermo Fisher Scientific
174. Tokai Pharmaceuticals
175. Turning Point Therapeutics
176. uBiome
177. Unilabs
178. USC Michelson Center for Convergent Bioscience
179. Vivia Biotech
180. Walgreens
181. Wondfo
182. XCR Diagnostics